DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Change in Examiner
The examiner of your application in the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Stephanie Sullivan, Art Unit 1635.
Election/Restrictions
Applicant’s election without traverse of “a composition comprising at least three harmonized RNA species”, consistent with Examples 2 and 5 and studies shown in Fig. 6 in the reply filed on 02/17/2026 is acknowledged.
Upon further consideration, the species election has been withdrawn due to the cited art teaching at least two harmonized RNA species.
Claims 55 and 71-94 are pending an under examination.
Priority
This application is a CON of 16/762,081 filed 05/06/2020 PAT 11,692,002 which is a 371 of PCT/EP2018/080692, filed 11/08/2018. This application also claims foreign priority to PCT/EP2017/078647, filed 11/08/2017, as reflected by the most recent filing receipt.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it exceeds 150 words, uses implied phrases (the present invention concerns…), and uses legal phraseology “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to because the drawings are labeled as “Figs.” or “Fig.” rather than “FIG.”. See 37 CFR 1.84 Standards for Drawings. (u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG."
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 55 and 71-94 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims recite the term “harmonized RNA” or depend from claims that recite “harmonized RNA”. “Harmonized RNA” is not a term in the art, and the specification as filed does not provide a specific definition of the term. While the specification provides guidance as to what may be a “harmonized RNA”, one in the art would need to make assumptions as to the terms definition to appreciate the metes and bounds of the claims. The claims, as presented, do not provide context for the term such that one in the art would know what is included and excluded from the claims.
While the examiner for the parent application, 16/762,081 dropped the 35 U.S.C. 112(b) rejection after the amendment to claim 29 adding “wherein said at least two RNA species each having a length of 800 to 20,000 nucleotides” and adding “that is no more than 50 different from each other” which also appear in instant claim 55, this amendment is not found persuasive in the instant claims, as the recitation that “each harmonized RNA species comprising a polynucleotide sequence having a harmonized number of A and U nucleotides that is no more than 50 nucleotides different from each other” does not describe what it means to have a harmonized number of A and U nucleotides and therefore, the metes and bounds of the claims are not clear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 90 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 90 depends on claim 89 which recites, “the composition of claim 88, wherein the at least three harmonized RNA species encoding Influenza A and Influenza B virus HA polypeptides”. Claim 90 recites, “the composition of claim 89, wherein the at least three harmonized RNA species encoding Influenza A and Influenza B virus HA polypeptides”. Therefore, claim 90 recites the exact same limitations of claim 89 and therefore does not further limit the subject matter of which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Interpretation
The instant specification does not provide a definition of “harmonized RNA species”. Example 2.1 of the instant specification discloses that sequence adaptation was performed such that the encoded amino acid sequence was unchanged, either by exploiting the degeneracy of the genetic code or by introducing an adenine stretch into the polyA tail or the UTR of the RNA molecule species (page 78). In addition, page 78 states in order to harmonize the retention times of a RNA molecule species encoding different HA antigens, GC-optimized DNA sequence encoding different HA proteins of Influenza B were adapted by increasing the number of A nucleotides by adapting the coding sequence, by elongating the polyA sequence or by introducing additional A nucleotides into the UTR region. Example 4 discloses optimizing GC DNA sequence encoding different influenza NA proteins by decreasing the number of A nucleotides by altering the coding sequence. Therefore, art that teaches a composition comprising at least two RNA species having the recited structure of the instant claims and having an increased or decreased number of A nucleotides reads on claim 55. The reference does not need to explicitly teach the RNA as “harmonized RNA species” as this does not appear to be a term used in the art.
Claims 55,71-73,75 and 78-83 are rejected under 35 U.S.C. 103 as being unpatentable over Ciaramella et al. (WO 2017070620, Published 27 April 2017) in view of CureVac (US 20100239608, Published 23 Sept 2010).
Regarding claims 55,71,78 and 79, Ciaramella et al. teach RNA (e.g., mRNA) vaccines which are multivalent (page 10, line 28), including influenza vaccines comprising multiple RNA polynucleotides, each encoding a single antigenic polypeptide (page 47, lines 5-8). Ciaramella et al. teach influenza vaccines comprising one or more RNA polynucleotides having an open reading frame encoding a hemagglutinin protein and a pharmaceutically acceptable carrier or excipient (page 23, lines 33-35), and teach embodiments where the RNA polynucleotide further encodes neuraminidase protein (page 24, line 2). Ciaramella et al. teach the basic components of an mRNA molecule typically include at least one coding region, a 5’UTR, a 3’UTR, a 5’ cap and a poly-A tail (page 39, lines 14-15). Ciaramella et al. teach naturally-occurring eukaryotic mRNA molecules have been found to contain stabilizing elements, including, but not limited to untranslated regions (UTR) at their 5 '-end (5'UTR) and/or at their 3'-end (3 'UTR), in addition to other structural features, such as a 5'- cap structure or a 3'-poly(A) tail (page 73, lines 16-19), and a polyA tail may contain 10-300 adenosine monophosphates, and functions to protect mRNA from enzymatic degradation in the cytoplasm, aids in transcription termination, export of the mRNA from the nucleus and translation (page 65, lines 3-9). Ciaramella et al. teach the polynucleotide includes 200-3000 nucleotides (page 65, line 10).
Ciaramella et al. do not teach the number of A and U nucleotides have been altered in the RNA encoding each of the influenza polypeptides.
Before the effective filing date, CureVac taught the object of the present invention is to provide a new system for gene therapy and genetic vaccination that overcomes the disadvantages associated with the properties of DNA therapeutic agents and DNA vaccines and that increases the effectiveness of therapeutic agents based on RNA species (paragraph 0019). CureVac taught a pharmaceutical composition containing at least one modified mRNA of the present invention and a pharmaceutically compatible carrier and/or vehicle are provided. The modified mRNA encodes at least one biologically active or antigenic peptide or polypeptide, wherein the sequence of the mRNA comprises at least one modification as set forth herein below as compared to the wild type mRNA. Such modifications may be located in the region coding for the at least one peptide or polypeptide, or in untranslated regions (paragraph 0021).
CureVac taught the G/C content of the region of the modified mRNA coding for the peptide or polypeptide is increased relative to that of the G/C content of the coding region of the wild type mRNA coding for the peptide or polypeptide. The encoded amino acid sequence, however, remains unchanged compared to the wild type (i.e. silent with respect to the encoded amino acid sequence) (paragraph 0022), and this modification is based on the fact that, for efficient translation of an mRNA, the sequence of the region of the mRNA to be translated is essential. In this connection the composition and the sequence of the various nucleotides play an important role. In particular sequences with an increased G (guanosine)/C (cytosine) content are more stable than sequences with an increased A (adenosine)/U (uracil) content. In accordance with the invention, the codons are varied compared to the wild type mRNA, while maintaining the translated amino acid sequence, so that they contain increased amounts of G/C nucleotides (paragraph 0023).
CureVac taught preferably the G/C content of the region of the modified mRNA coding for the peptide or polypeptide is increased by at least 7%, more preferably by at least 15%, and particularly preferably by at least 20% compared to the G/C content of the coded region of the wild type mRNA encoding for the polypeptide (paragraph 0029). CureVac also taught for efficient translation of the mRNA a productive binding of the ribosomes to the ribosome binding site [Kozak sequence: GCCGCCACCAUGG (SEQ ID NO: 13), the AUG forms the start codon] is generally required. In this regard it has been established that an increased A/U content around this site facilitates more efficient ribosome binding to the mRNA (paragraph 0045).
Regarding claim 72, Ciaramella et al. also teach a vaccine comprising at least one RNA polynucleotide having an open reading frame encoding a HA protein, or immunogenic fragment thereof, and a NA protein, or immunogenic fragment thereof, obtained from influenza virus (page 25 lines 30-33).
Regarding claim 73, Ciaramella et al. teach a vaccine comprising at least one RNA having an ORF encoding a HA protein (HA or derivatives thereof comprising antigenic sequences from HA1 and/or HA2) (page 30, lines 15-17).
Regarding claim 75, Ciaramella et al. teach the RNA vaccines of the present disclosure comprise 2-10 or more RNA polynucleotides each of which encodes a different antigenic polypeptide and may be selected from any of the influenza antigenic polypeptides described herein (page 47, lines 15-20).
Regarding claims 80 and 81, Ciaramella et al. teach the influenza RNA vaccine is formulated in a lipid-polycation complex, referred to as a cationic lipid nanoparticle (page 75, lines 8-10), and an influenza RNA (e.g., mRNA) vaccine of any one of the foregoing paragraphs formulated in a nanoparticle (e.g., a lipid nanoparticle) (page 10, lines 13-14). Ciaramella et al. teach the surprising finding that lipid nanoparticle (LNP) formulations significantly enhance the effectiveness of mRNA vaccines, including chemically modified and unmodified mRNA vaccines. The efficacy of mRNA vaccines formulated in LNP was examined in vivo using several distinct antigens. The results presented herein demonstrate the unexpected superior efficacy of the mRNA vaccines formulated in LNP over other commercially available vaccines. In addition to providing an enhanced immune response, the formulations of the invention generate a more rapid immune response with fewer doses of antigen than other vaccines tested. The mRNA-LNP formulations of the invention also produce quantitatively and qualitatively better immune responses than vaccines formulated in a different carriers (page 37, lines 29-34 and page 38, lines 1-4).
Regarding claims 82-83, Ciaramella et al. teaches a vaccine that includes at least one RNA polynucleotide having an ORF encoding at least one influenza antigenic polypeptide, wherein at least 80% of the uracil in the open reading frame having a chemical modification, and embodiments where 100% of the uracil in the ORF have a N1-methylpseudouridine in the 5-position of the uracil (page 9, lines 4-14). Ciaramella et al. teach the RNA vaccines of the present disclosure comprise 2-10 or more RNA polynucleotides each of which encodes a different antigenic polypeptide and may be selected from any of the influenza antigenic polypeptides described herein (page 47, lines 15-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have modified each of the RNAs encoding each influenza antigen in the vaccine of Ciaramella et al. with the teachings of CureVac regarding increasing the G/C content of the coding region of the wild type mRNA coding for the peptide or polypeptide or increasing A/U content around the ribosome binding site in order to provide a multivalent RNA vaccine wherein each RNA encoding the influenza polypeptide antigens has increased stability with a reasonable expectation of success. There would be a reasonable expectation of success, because CureVac also pertains to RNA vaccines.
One of ordinary skill in the art would have been motivated to do so because CureVac taught a new system for genetic vaccination that overcomes the disadvantages associated with the properties of DNA therapeutic agents and DNA vaccines and that increases the effectiveness of therapeutic agents based on RNA species (paragraph 0019). CureVac taught the G/C content of the region of the modified mRNA coding for the peptide or polypeptide is increased relative to that of the G/C content of the coding region of the wild type mRNA coding for the peptide or polypeptide, while the encoded amino acid sequence remains unchanged compared to the wild type and particular sequences with an increased G (guanosine)/C (cytosine) content are more stable than sequences with an increased A (adenosine)/U (uracil) content. CureVac also taught for efficient translation of the mRNA a productive binding of the ribosomes to the ribosome binding site [Kozak sequence: GCCGCCACCAUGG (SEQ ID NO: 13), the AUG forms the start codon] is generally required. In this regard it has been established that an increased A/U content around this site facilitates more efficient ribosome binding to the mRNA (paragraph 0045).
While Ciaramella et al. in view of CureVac does not explicitly teach that each RNA encoding each polypeptide have a harmonized number of A and U nucleotides that is no more than 50 nucleotides, or 20 nucleotides or no more than 10 nucleotides different from each other, one of ordinary skill in the art would be motivated for each RNA encoding the influenza antigens of Ciaramella et al. that if the same modifications are applied to each RNA in the vaccine (increasing G/C content in the coding region and/or increasing A/U content near the ribosome binding site), that there would be a similar number of such modifications applied to each RNA species to fall within the recited limitations regarding the number of added or removed A and U nucleotides in each RNA. Absent demonstration of the criticality of the nucleotide difference, it is concluded that the normal desire of scientists or artisans to improve upon what is generally known would provide motivation to determine where in a disclosed set of ranges is the optimum number of nucleotides different from each other of the harmonized RNA species. Note: MPEP 2144.05.
Accordingly, the limitations of claims 55,71-73,75 and 78-83 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date.
Claims 74,76,77 and 84-94 are rejected under 35 U.S.C. 103 as being unpatentable over Ciaramella et al. in view of CureVac as applied to claims 55,71-73,75 and 78-83 above, and further in view of Radosevic et al. (US 20130236494, Published 12 Sept 2013).
The teachings of Ciaramella et al. in view of CureVac as applied to claims 55,71-73,75 and 78-83 have been described above.
Ciaramella et al. teach an influenza RNA (e.g., mRNA) vaccine of any one of the foregoing paragraphs formulated in a nanoparticle (e.g., a lipid nanoparticle) (page 10, lines 13-14), and a vaccine that includes at least one RNA polynucleotide having an ORF encoding at least one influenza antigenic polypeptide, wherein at least 80% of the uracil in the open reading frame having a chemical modification, and embodiments where 100% of the uracil in the ORF have a N1-methylpseudouridine in the 5-position of the uracil (page 9, lines 4-14).
Ciaramella et al. and CureVac do not teach at least two RNAs encoding a different Influenza virus NA polypeptide or antigenic fragment thereof, or at least three RNAs each encoding a different HA polypeptide or antigenic fragment thereof or at least three RNAs each encoding a different Influenza virus NA polypeptide or antigenic fragment thereof.
Before the effective filing date, Radosevic et al. teach a vaccine to be used according to the disclosure is preferably a pharmaceutical composition, and usually includes components in addition to the influenza antigens, e.g., it typically includes one or more pharmaceutically acceptable carrier(s) and/or excipient(s) (paragraph 0072). Radosevic et al. teach a seasonal vaccine comprising HA and NA proteins of at least three influenza strains, for use in inducing protection against the three influenza strains and cross-protection against at least one heterologous influenza strain within the same subtype as compared to at least one of the influenza strains, and also against at least one heterosubtypic influenza strain of which no HA and NA antigens are present in the vaccine (paragraph 0035). Radosevic et al. teach an influenza vaccine that comprises HA and NA from an H1N1, an H3N2 and a B strain of influenza, for use in inducing cross-protection against a pandemic or potentially pandemic influenza strain (paragraph 0027), depending on the particular season and on the nature of the antigen included in the vaccine, the influenza antigens may be derived from one or more of the following hemagglutinin subtypes: influenza A H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15 or H16; or influenza B; and one or more of the following neuraminidase subtypes: influenza A N1, N2, N3, N4, N5, N6, N7, N8, or N9; or influenza B. For the majority of the HA subtypes, H1-H7 and H9-H12, all combinations with the 9 NA subtypes have been observed. Exemplary important combinations for influenza A comprise, but are not limited to: H1N1, H2N2, H3N2, H3N1, H5N1, H5N2, H7N7, H1N2, H9N2, H7N2, H7N3 and H10N7. Typically, a seasonal influenza vaccine comprises HA and NA of three influenza strains, which nowadays typically include a H1N1, a H3N2 and at least one B strain. Quadrivalent seasonal vaccines typically include antigens from an additional B strain (typically such vaccines comprise antigens from both a Yamagata and from a Victoria lineage B strain) (paragraph 0062).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have substituted the RNAs encoding each influenza antigen in the vaccine composition of Ciaramella et al. in view of CureVac with the specific combinations of influenza antigens of Radosevic et al. with a reasonable expectation of success. There would be a reasonable expectation of success, as Ciaramella et al., CureVac and Radosevic et al. al pertain to vaccines, and Ciaramella et al. and Radosevic et al. pertain to influenza vaccines, and would amount to simple substitution of one known element for another to obtain predictable results.
One of ordinary skill in the art would have been motivated to provide at least two RNAs or at least three RNA’s encoding a different Influenza virus NA polypeptide, or at least three RNAs encoding a different Influenza virus HA polypeptide because Radosevic et al. taught a seasonal vaccine comprising HA and NA proteins of at least three influenza strains, for use in inducing protection against the three influenza strains and cross-protection against at least one heterologous influenza strain and depending on the particular season and on the nature of the antigen included in the vaccine, the influenza antigens may be derived from one or more of the following hemagglutinin subtypes: influenza A H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15 or H16; or influenza B; and one or more of the following neuraminidase subtypes: influenza A N1, N2, N3, N4, N5, N6, N7, N8, or N9; or influenza B.
One of ordinary skill in the art would have been motivated to provide at least three RNAs encoding Influenza A and Influenza B HA polypeptides, and wherein the at least three RNAs encode Influenza HA polypeptides from Influenza H1N1 virus, an Influenza H3N2 and an Influenza B virus, or wherein the at least three RNAs encoding Influenza A and Influenza B HA polypeptides, including Influenza HA-A and Influenza HA-B polypeptide, and wherein the at least three RNAs encoding Influenza HA polypeptide from Influenza H1N1 virus, Influenza H3N2 and an Influenza B virus, in the vaccine composition of Ciaramella et al. in view of CureVac, because Radosevic et al. teach an influenza vaccine that comprises HA and NA from an H1N1, an H3N2 and a B strain of influenza, for use in inducing cross-protection against a pandemic or potentially pandemic influenza strain (paragraph 0027), depending on the particular season and on the nature of the antigen included in the vaccine, the influenza antigens may be derived from one or more of the following hemagglutinin subtypes: influenza A H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15 or H16; or influenza B; and one or more of the following neuraminidase subtypes: influenza A N1, N2, N3, N4, N5, N6, N7, N8, or N9; or influenza B, and for the majority of the HA subtypes, H1-H7 and H9-H12, all combinations with the 9 NA subtypes have been observed. Exemplary important combinations for influenza A comprise, but are not limited to: H1N1, H2N2, H3N2, H3N1, H5N1, H5N2, H7N7, H1N2, H9N2, H7N2, H7N3 and H10N7. Typically, a seasonal influenza vaccine comprises HA and NA of three influenza strains, which nowadays typically include a H1N1, a H3N2 and at least one B strain. Quadrivalent seasonal vaccines typically include antigens from an additional B strain (typically such vaccines comprise antigens from both a Yamagata and from a Victoria lineage B strain) (paragraph 0062).
Accordingly, the limitations of claims 74,76,77 and 84-94 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 55 and 71-94 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,692,002. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 1-21 of Patent 11,692,002 recite a method for analysis or purification of a mixture comprising at least two harmonized RNA species, the method comprising a) obtaining the coding sequence for at least two RNA species, said at least two RNA species each having a length of 800 to 20,000 nucleotides wherein the sequence of at least one RNA species is adapted by altering the number of A and/or U nucleotides in the RNA sequence with respect to the number of A and/or U nucleotides in the original RNA sequence, said coding sequences of the at least two RNA species having a harmonized number of encoded A and U nucleotides that is no more than 50 different from each other; b) synthesizing the at least two RNA species to produce at least two harmonized RNA species, c) analysing and/or purifying a mixture of said at least two harmonized RNA species by chromatography. Claim 9 of Patent 11,692,002 recites the elements of a 5’ cap structure, a 5’-UTR element, at least one coding region, a 3’ UTR element, and a poly(A) sequence comprising 10-200; claim 10 recites the at least two RNA species each encode different Influenza virus hemagglutinin antigens; and claim 13 recites there are at least three RNA species that encode different influenza HA antigens.
Therefore, instant claims 55 and 71-94 which recites a composition comprising at least two harmonized RNA species formulated in a pharmaceutically acceptable carrier, each of said at least two harmonized RNA species comprising a 5’ Cap structure, a 5’ UTR, at least one coding region encoding a polypeptide, a 3’UTR, and a poly(A) sequence comprising 10-200 nucleotides, wherein said harmonized RNA species each encode a polypeptide having a different amino acid sequence, each harmonized RNA species comprising a polynucleotide sequence having a harmonized number of A and U nucleotides that is no more than 50 nucleotides different from each other, and wherein said harmonized RNA species are each 800 to 20,000 nucleotides in length, is a product having the same structure as the RNA species recited in Patent 11,692,002, and recites the same RNA species as encoding different Influenza virus hemagglutinin antigens, claims including at least three RNA species including from different influenza HA antigens, RNA species encoding different influenza virus neuraminidase antigens, and would be an obvious product that would result from the method recited in Patent 11,692,002.
Therefore instant claims 55 and 71-94 are an obvious variant and product that results from the method of claims 1-22 of Patent 11,692,002 and are not patentably distinct from each other.
It is noted that since the instant application is a CON, the 121 shield does not apply.
Conclusion
Claims 55 and 71-94 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE L SULLIVAN whose telephone number is (703)756-4671. The examiner can normally be reached Monday-Friday, 7:30-3:30 EST.
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/STEPHANIE L SULLIVAN/Examiner, Art Unit 1635
/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
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